Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans

December 20, 2011 updated by: Dr. Peter Jones, University of Manitoba

Naturalis Clinical Trial for a Novel Phytosterol Formulation

The aim of this clinical study was to determine the efficacy on plasma cholesterol-lowering of a water dispersible formulation of plant sterol (WD-PS) preparation versus plant sterol esters (PS-ester), consumed within dairy products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Forty-seven hyperlipidemic subjects (25 males and 22 females, age 19-75 years at baseline) completed the double-blind, randomized, crossover study.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • Richarson Centre for Funtional Foods and Nutraceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy individuals aged 19-60 yr
  • plasma LDL-C levels > 3.0mmol/l
  • TG < 4.5mmol/l
  • body mass index (BMI) between 20 and 30 kg/m2.

Exclusion Criteria:

  • history of recent or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 3 months
  • history of chronic use of alcohol (>2 drinks/d)
  • smoking
  • myocardial infarction, coronary artery bypass, sitosterolaemia, kidney disease, liver disease or other major surgical procedures within the last six months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Water dispersible Plant Sterol (WD-PS)
WD-PS dairy product (a novel formulation for dispersible free sterols in aqueous media produced)2g/d of free plant sterol
Dietary supplement: WD-PS intervention phase
2g/d of free plant sterol in 100g yogurt
Experimental: Esterified plant sterol (PS-Ester)
PS-Ester enriched dairy product (2g/d free plant sterol)
Dietary supplement: PS-Ester intervention phase
2g/d of free plant sterol in 100g yogurt
Placebo Comparator: placebo
100 g/d yogurt with no added plant sterol
Dietary supplement: placebo
100g/d yogurt with no added plant sterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid Profile
Time Frame: Change from Baseline in lipid profile at 4 weeks (end of the phase)
Change from Baseline in lipid profile at 4 weeks (end of the phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

December 21, 2011

Last Update Submitted That Met QC Criteria

December 20, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2010:096

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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